RP1 (vusolimogene oderparepvec) and OPDIVO (nivolumab) - (IGNYTE-3)

July 30, 2026: Replimune Group, Inc. (NASDAQ: REPL) said the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee reviewed the BLA resubmission for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma patients who progressed after prior anti-PD-1 therapy. The committee discussed whether the single-arm IGNYTE study supports a reliable assessment of expected response rate and duration of response in the proposed population, and whether the reported responses were clinically meaningful and indicative of systemic antitumor activity attributable to RP1.

The advisory committee voted 10-3 that the efficacy results from IGNYTE are evaluable and clinically meaningful. Replimune characterized the outcome as supportive as the FDA continues its review.

The upcoming catalyst is the FDA target action date for the Class 1 BLA resubmission: August 2, 2026.